FDA UDI
In Commercial Distribution
🇺🇸 United States
UltrOx
DI: 10841436123140
·
Model: 610-2472
·
CIVCO MEDICAL INSTRUMENTS CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
60
Basic Information
- Brand Name
- UltrOx
- Primary DI
- 10841436123140
- Version / Model
- 610-2472
- Catalog Number
- 610-2472
- Company Name
- CIVCO MEDICAL INSTRUMENTS CO., INC.
- Labeler DUNS
- 134614411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2023-05-03
- Public Version
- 1
- Public Version Date
- 2023-05-11
- Public Version Status
- New
- Public Device Record Key
- 31361df7-9182-401c-9aa1-3d15f4b9eaf8
Device Description
UltrOx Test Strips
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOJ | Indicator, physical/chemical sterilization process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58107 | Hydrogen peroxide device disinfectant/sterilant test strip | A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of hydrogen peroxide (H2O2) in a device disinfectant and/or sterilant solution after preparation to ensure disinfectant/sterilant properties. It is used to prevent diluting the disinfectant/sterilant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00841436123143 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 10841436123140 | GS1 | ||||
| Unit of Use | 80841436123149 | GS1 |
Customer Contacts
- Phone
- +1(319)248-6502
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 43 – 86 Degrees Fahrenheit